Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leeds

About this trial

This will be an observational study to explore differences in pathophysiology between groups of people with and without heart failure (HF) (reduced and preserved ejection fraction) and with and without diabetes mellitus (DM) with a particular focus on cross-talk (fat, muscle, vascular tissue and the heart). The investigators will invite 600 people to partcipate (100 with HFrEF+DM, 100 with HFpEF+DM, 100 with HFpEF-DM, 100 with HFrEF-DM, 100 with DM, 100 without either HR or DM). Special heart scans, exercise testing, blood testing, testing of the automatic nervous system will be performed and in some, samples of fat and muscle and endothelial cells will be collected.

These data will be used to create a cohort of well phenotyped patients with a variety of comprehensively collected clinical information, a cell atlas, and a comprehensive assessment of metabolomics, proeomics and cross-talk in between tissues, allowing comparisons between each group.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >18 years

Ability to provide written informed consent

Persons who are legally competent and mentally able to follow the instructions of the study staff

Disqualifiers

Anaemia Hb <8 mg/dl

Patients with acute infectious diseases (e.g. pneumonia)

Patients with heart failure due to sepsis

People with acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress

Trial population

People attending heart failure clinics, diabetes clinics (either secondary or primary care) or control subjects attending hospital with relatives or accumulated from the community by word of mouth or advertisement.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: HFrEF-DM
Group B: HFrEF+DM
Group C: HFpEF-DM
Group D: HFpEF+DM
Group E: DM
Group F: Control

Trial outcomes

Primary outcomes

1

Study primary endpoint

Are there differences in skeletal muscle cellular metabolism assessed by mass spectrometry-based metabolomics and lipidomics between the two phenotypes of heart failure compared with controls and what influence does diabetes mellitus have?

Time frame
5 years

Secondary outcomes

1

Secondary outcome 1

How does T2DM influence intercellular communication to promote the progression of HF

Time frame
5 years
2

Secondary outcome 2

Are there correlations between abnormalities in these cells and cardiac abnormalities, patient symptoms and clinical outcomes?

Time frame
5 years
3

Secondary outcome 3

What metabolic pathways are abnormal in people with heart failure, diabetes mellitus and both?

Time frame
5 years
4

Secondary outcome 4

Can we identify using metabolomics, a substrate or compound that underlies the metabolic abnormalities?

Time frame
5 years

Other outcomes

Sponsors and contacts

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